Purple Book reference family · 351(a) biologic
efbemalenograstim alfa-vuxw (Ryzneuta)
efbemalenograstim alfa-vuxw is an FDA-licensed reference biologic from Evive Biotechnology Singapore PTE. LTD..
351(a) biologicBLA 761134 Evive Biotechnology Singapore PTE. LTD.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 761134
Ryzneuta efbemalenograstim alfa-vuxw
Evive Biotechnology Singapore PTE. LTD.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference efbemalenograstim alfa-vuxw product.
2 yr 9 mo ago
efbemalenograstim alfa-vuxw: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for efbemalenograstim alfa-vuxw.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
